FDA 510(k) Microbiology Devices
FDA 510(k) Microbiology Devices - Regulatory Overview
FDA 510(k) microbiology devices include diagnostic systems used to detect and identify bacteria, viruses, fungi and parasites. The FDA review panel code is MI.
Key device types:
- Blood culture systems - automated incubation and detection platforms
- Microbial identification - MALDI-TOF, biochemical and molecular ID systems
- Antimicrobial susceptibility testing - MIC determination and breakpoint analysis
- Rapid infectious disease tests - influenza, strep, RSV, COVID-19 antigen and molecular tests
- Molecular diagnostics - PCR panels for respiratory, GI and STI pathogens
7067
Total
7005
Cleared
149d
Avg (2y)
1976
Since
5925 Microbiology devices
Cleared
Jul 25, 2022
BioFire COVID-19 Test 2
QQX
Respiratory Specimen Nucleic Acid Sars-cov-2 Test
67d
Cleared
Jul 22, 2022
BioFire JI Control Panel M420
PMN
Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays
582d
Cleared
Jul 15, 2022
Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)
QLX
Nucleic Acid Amplification Test For The Quantitation Of Epstein-barr Virus (ebv) Dna
317d
Cleared
Jul 14, 2022
LIAISON MeMed BV, LIAISON MeMed BV Control Set
QPS
Immunoassay For Host Biomarkers Of Infection
210d
Cleared
Jul 12, 2022
VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
210d
Cleared
Jul 11, 2022
Revogene
OOI
Real Time Nucleic Acid Amplification System
143d
Cleared
Jul 06, 2022
cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System
OCC
Respiratory Virus Panel Nucleic Acid Assay System
210d
Cleared
Jun 24, 2022
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
PBK
Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set
1d
Cleared
Jun 24, 2022
ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2
OZE
Influenza A And Influenza B Multiplex Nucleic Acid Assay
98d
Cleared
Jun 23, 2022
BreathID Hp Lab System, BreathID Smart System
MSQ
Test, Urea (breath Or Blood)
121d
Cleared
Jun 10, 2022
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
PBK
Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set
2d
Cleared
Jun 07, 2022
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
PQA
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
47d
Cleared
Jun 03, 2022
Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris
QEP
Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
120d
Cleared
Jun 03, 2022
VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
169d
Cleared
May 20, 2022
Disposable Sampler Viral Transport Media
JSM
Culture Media, Non-propagating Transport
389d
Cleared
May 19, 2022
ARCHITECT Toxo IgG
LGD
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
444d
Cleared
May 10, 2022
BD CTGCTV2
QEP
Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
438d
Cleared
May 09, 2022
Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System
NJR
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
535d
Cleared
May 04, 2022
BioTeke Sterile Disposable Virus Sampling Kit
JSM
Culture Media, Non-propagating Transport
335d
Cleared
Apr 29, 2022
Alinity m STI Assay
QEP
Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
576d
Not Cleared
Apr 29, 2022
BioFire Joint Infection (JI) Panel
QSN
Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
549d
Cleared
Apr 27, 2022
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
PEN
Gram-negative Bacteria And Associated Resistance Markers
209d
Cleared
Apr 14, 2022
VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
113d
Cleared
Mar 16, 2022
Healgen Strep A Rapid Test Strip (Throat Swab)
GTY
Antigens, All Groups, Streptococcus Spp.
210d
Cleared
Mar 15, 2022
VITEK MS PRIME
QBN
Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
221d
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